Crystaline II 5101H-II

GUDID 20815236020098

Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 50

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use

• Primary Device ID: 20815236020098
• NIH Device Record Key: fca14909-839e-4b91-8c7a-b4b60ac15ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crystaline II
• Version Model Number: 5101H-II
• Catalog Number: 5101H-II
• Company DUNS: 059247507
• Company Name: LCR HALLCREST, LLC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-325-3671
• Email: mailbox@sharn.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815236020094 [Unit of Use]
GS1	10815236020091 [Primary]
GS1	20815236020098 [Package]; Contains: 10815236020091; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• KPD: Strip, Temperature, Forehead, Liquid Crystal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-23

On-Brand Devices [Crystaline II]

• 20815236020166: Crystaline II Liquid Crystal Temperature Trend Indicators - Dispenser of 5
• 10815236020152: Crystaline II Liquid Crystal Temperature Trend Indicators - Poly Bag of 2
• 30815236020132: Crystaline II Liquid Crystal Temperature Trend Indicators - Envelope of 1
• 10815236020121: Crystaline II Liquid Crystal Temperature Trend Indicators - Box of 125
• 20815236020111: Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 125
• 20815236020104: Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100
• 20815236020098: Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 50
• 20815236020081: Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 25.
• 00815236020100: Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100 - CE Marked